Kornimate/medical-research-clean huggingface dataset:
phase ii study of high-dose cyclophosphamide in patients with refractory pemphigus

Conditions: Pemphigus

Summary: objectives: i. determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.

protocol outline: patients receive cyclophosphamide iv on days 1-4 and filgrastim (g-csf) beginning on day 10 and continuing until blood counts recover. patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- definitive diagnosis of pemphigus, including all of the following: typical clinical lesions histologically proven by skin or mucous membrane biopsy pemphigus igg autoantibodies in skin or mucous membrane by direct immunofluorescence (if) circulating pemphigus igg autoantibodies in serum by indirect if dependence on high-dose corticosteroids persistent disease activity despite treatment with mycophenolate mofetil or azathioprine, or inability to tolerate these drugs (for paraneoplastic pemphigus, persistent disease activity despite treatment with cyclosporine) --prior/concurrent therapy-- no concurrent cytotoxic therapy --patient characteristics-- performance status: karnofsky 20-100% renal: creatinine no greater than 2.5 mg/dl cardiovascular: lvef at least 40% pulmonary: fvc, fev1, or dlco at least 50% predicted other: not pregnant fertile patients must use effective contraception during and for 9 months after study not preterminal or moribund

Keywords: immunologic disorders and infectious disorders pemphigus rare disease
is vitamin d deficiency linked to functional constipation in children

Conditions: Functional Constipation in Children

Summary: constipation is one of the most common causes of patient visits to pediatric clinics. prevalence of constipation is estimated between 1.9-27.2% in the usa (rasquin et al., 2006). in children aged \<18 years, its prevalence was about 0.7-29.6%. untreated constipation may cause fecal impaction and fecal soiling5 which are seen in about 1-3% of children (bulloch and tenenbein, 2002). constipation may cause gastrointestinal problems such as abdominal pain, anal pruritus, rectal bleeding, and anorexia or non-gastrointestinal complications such as urinary problems (dehghani et al., 2015). functional constipation is defined as constipation without an organic etiology and is diagnosed according to the rome criteria1-3. the symptom- based rome criteria were first developed for adults in 1989 during a consensus meeting of experts in the field of functional gastrointestinal disorders. these criteria have been updated several times and are now internationally acknowledged and used for both research and clinical purposes. the revised rome iv criteria- for childhood and adult functional constipation were published in 2016 (benninga et al., 2016), (hyams et al., 2016), (lacy et al., 2016). functional constipation, a common disorder in all age groups, shows some similarities in children and adults, but important differences exist regarding epidemiology, symptomatology, pathophysiology, diagnostic workup and therapeutic management. in this research, we hypothesized that serum vitamin d deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.

in this research, we hypothesized that serum vitamin d deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.

Eligibility criteria:
inclusion criteria: - all pediatric patients from 6 to 16 years old who were diagnosed with chronic constipation in gastrointestinal and hepatology clinic, at benha university hospital according to revised rome iv criteria will be consecutively recruited in this study. sex- and age-matched approximate-health children will be recruited as a control group. exclusion criteria: * 1)- age \ 16 years old. 2)- children with any chronic medical disease. 3)- children who receive any medications. 4)- children with organic causes of constipation such as anal fissure, stenosis or stricture, inflammatory bowel disease and intestinal malabsorption.

Keywords: vitamin d deficiency functional constipation children
study and follow-up of the clinical effectiveness and comparative safety of biosimilar teriparatide in the management of postmenopausal or senile.

Conditions: Osteoporosis

Summary: non-interventional observational prospective follow-up study of cohorts of patients with previous diagnosis of osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.

non-interventional observational prospective follow-up study of cohorts of patients with previous diagnosis of osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents. primary objective: verify the clinical effectiveness of teriparatide biosimilar under clinical practice conditions real. compare this clinical effectiveness with original teriparatide administered under similar conditions of actual clinical practice. design: observational cohort study, prospective, multicenter, nationwide. study population: patients with a previous diagnosis of osteoporosis with a high risk of fractures,with/without previous fractures and in treatment with bone formers since before the start of the study. the patients will be distributed into 2 cohorts based on whether they are receiving similar teriparatide (cohort a) or original teriparatide (cohort b).

Eligibility criteria:
inclusion criteria: * signing the informed consent men or women of legal age who have completed somatic growth. * previous diagnosis of densitometric osteoporosis in any location (densitometry with dexa diagnosis within 6 months prior to start of treatment) or previous diagnosis of established osteoporosis (due to previous low-impact fracture, central or peripheral) * being in previous treatment with similar teriparatide (cohort a) or with original teriparatide (cohort b). * be in possession of mental faculties to understand the therapeutic proposal, understand and follow the follow-up protocol and be able to sign the consent document informed. exclusion criteria: * the informed consent signature was not obtained. * patients who meet any of the contraindications for the use of teriparatide.

Keywords: osteoporosis risk fracture postmenopausical forsteo movymia
pns vs rfa for facet joint pain

Conditions: Facet Joint Pain

Summary: radiofrequency ablation of the medial nerve is the current surgical treatment for back pain originating from the facet joints in the spine. however, this procedure causes denervation of spinal muscles. peripheral nerve stimulation is another treatment for facet joint pain that may not cause damage to the spinal muscles. this study will compare both treatments in terms pain relief and spine biomechanics.


Eligibility criteria:
inclusion criteria: 1. age range (18-80 years): the age range of the patient population at hershey medical center with facet pain is 24 to 90 years old, with a mean age of 63 years old. due to the physical tests planned in the study, the maximum age limit will be restricted to 80 years old. 2. english speaking: adults who only speak other languages will not be included because of the lack of feasibility of employing reliable instruments and interviewers fluent in other languages. 3. facet joint pain: male and female patients having a diagnosis of facet joint pain based upon accepted diagnostic criteria (i.e., two positive nerve blocks) and assessed by an experienced physical therapist or physician. 4. indication for surgical procedure: physical therapy is the first line of action for facet joint pain. if pt is not effective, patients are eligible for rfa or pns. exclusion criteria: 1. previous spinal conditions surgery: we will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries. 2. systemic neurological or neuromuscular disease: such disorders (e.g., stroke, muscular dystrophy, myopathies) affect muscle and may confound muscle data and/or balance and physical performance data. 3. allergic reaction to ultrasound gels: it is possible, although rare, that patients develop allergic reaction to ultrasound gels. those subjects will be excluded from the study. 4. physical activity: subjects will be asked to fill out the physical activity readiness questionnaire (par-q), and if they answer yes to any of the questions, they need to be cleared by their physician prior to participating in the study. 5. current infection, illness, or condition: individuals with a current infection, illness, or condition (e.g., uncontrolled blood pressure, pregnancy) that may affect their ability to safely participate will be excluded. 6. mental incompetency: individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion. 7. patients who have a deep brain stimulation (dbs) system. 8. patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator). 9. patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the sprint system.
the objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting

Conditions: Cardiac Arrhythmia

Summary: the objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting.

outcome data collected from this study will provide the basis for post-market surveillance (pms) reporting, clinical study report (csr), clinical evaluation report (cer) on alcis devices and support peer-reviewed publications on products performance and safety.

Eligibility criteria:
inclusion criteria: to be included, patients must be: * 18 to 90 years old * patient who have to undergo diagnostic procedure or ablation procedure (cardiac arrythmias) * informed and willing to sign an informed consent for approved by ec * affiliation to the social security or foreign regime recognized in france exclusion criteria: a patient will not be eligible to participate in the study if any of the following conditions are present: * not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times). * any medical condition that could impact the study at investigator's discretion (e.g. allergy...). * pregnant women * adult subject to legal protection measure
comparison of efficacy of 35% glycolic acid vs 20% salicylic acid peel in the treatment of post acne scars

Conditions: Post Acne Scars

Summary: the goal of this clinical trial is to compare the effectiveness of two drugs in patients that presents with scars on face after acnes. the effectiveness will be measured by a goodman and baron scale. one group of patients will receive 35% glycolic acid while other group of patients will receive 20% salicylic acid and both groups will be followed by 12 weeks.


Eligibility criteria:
inclusion criteria: * patients aged 18-45 years with mild to moderate atrophic post acne scars * fitzpatrick skin type 2-4 * no active acne or ongoing systemic acne treatment exclusion criteria: * pregnancy and breast feeding * history of keloid or hypertrophic scars * use of retinoids or chemical peel in last 3 months * active skin infections * history of hyperpigmentation after any procedure * hypersensitivity to aspirin
water intake and weight control in older adults

Conditions: Overweight and Obesity

Summary: this study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different diet prescriptions: 1) pre-meal water consumption (500 ml, before each main meal) with a hypocaloric diet; 2) 1500 ml water consumed throughout the day with a hypocaloric diet; 3) hypocaloric diet with no instructions regarding water consumption. smart water bottles will objectively assess water intake timing and volume. urine osmolality, urine volume, and serum osmolality will be used as objective indicators of compliance with the water intake prescription. we will investigate changes in perceived hunger and fullness and appetite-regulating hormones as potential mechanisms by which premeal water could improve appetite regulation. we will also investigate the impact of water consumption and hydration on executive function capabilities, which may influence intervention adherence. although increasing water intake could be an effective weight management strategy, no evidence-based recommendations exist for the timing of water intake needed for this benefit.


Eligibility criteria:
inclusion criteria: * aged 50+ years * bmi ≥25 kg/m2 * weight stable (+/- 2 kg) in past 6 months * willing to provide consent and comply with study protocol exclusion criteria: * usual plain drinking water intake \>1500 ml/d * uncontrolled hypertension (\>159/99 mmhg) * medical condition requiring specialized diet prescription (eg, t2d, chf wih fluid restriction) * medical condition that precludes participating in a physical activity program (eg, orthopedic injury) * current or history of gi disease (eg, crohn's), gi surgery, or medications which impact gi function * allergies or aversions to foods included in the test meals
brius vs ffa efficiency

Conditions: Dental Malocclusion; Angle Class II; Angle Class I; Crowding, Tooth

Summary: the purpose of this study is to compare the full fixed preadjusted appliances (regular braces) when to the brius system.

this is a randomized controlled trial which aims to identify the effectiveness of alignment in the brius group when compared to the full fixed appliance group. the secondary aim of the study is to identify any difference in discomfort experienced by the patients when undergoing treatment using the two appliances the investigators also aim to quantify the extent of tooth movement that is achieved through each appliance within a given time frame

Eligibility criteria:
inclusion criteria: * 10 to 18 years old * angle class i and cl ii (up to half cusp) molar and canine relationship. * fully erupted permanent dentition (excluding third molars). * crowding of 7 mm or less. * must be able to maintain good oral hygiene assessed by the orthodontist during their visits. exclusion criteria: * previous history of orthodontic treatment or orthognathic surgery * subjects who require extractions or orthognathic surgery * multiple missed appointments * deteriorating oral hygiene and craniofacial syndromes or disorders * severe gag reflex resulting from the use of intra-oral scanners
anterior lingual frenectomy is inadequate in improving breastfeeding outcomes: a prospective cohort study

Conditions: Ankyloglossia; Breastfeeding

Summary: a previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. in the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the p.i. in the office. the proposed study will only look at those babies who did undergo a previous frenotomy to determine: 1. the presence of continued problematic breastfeeding symptoms 2. if further tongue tie or lip tie release improves those outcomes


Eligibility criteria:
inclusion criteria: * healthy babies who are breastfeeding * had a previous frenotomy prior to presenting to the p.i. exclusion criteria: * twins, triplets * maternal breast surgery or igt * premature birth * significant heart/lung/brain disease of infant

Keywords: ankyloglossia breastfeeding lip tie
to investigate safety and efficacy of novoeight® (rfviii) during long-term treatment of haemophilia a in japan

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this study is conducted in asia. the aim of this study is to evaluate the safety and efficacy of novoeight® (recombinant factor viii) in patients with haemophilia a in japan in the setting of routine clinical practice.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedure related to recording of data according to the protocol * male and female patients with the diagnosis of haemophilia a * age range is 0 year and above * a decision to initiate treatment with commercially available novoeight® has been made by the patient/parent and the physician exclusion criteria: * known or suspected allergy to study product(s) or related products * previous participation in this study. participation is defined as informed consent obtained * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
evaluation of post-traumatic stress among the nearest relatives of brain-dead organ donors

Conditions: Stress Disorders, Post-Traumatic; Tissue Donors; Tissue and Organ Procurement

Summary: the goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.


Eligibility criteria:
inclusion criteria: * must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased exclusion criteria: * refusal to participate * does not speak french * deaf/mute * adult, but under guardianship
a retrospective study of subjects with thymidine kinase 2 deficiency

Conditions: Thymidine Kinase 2 Deficiency

Summary: this is a multicenter, multinational, retrospective chart-review study to evaluate survival in patients with thymidine kinase 2 deficiency (tk2d).

this is a retrospective, chart-review study. the primary goal is to use data on survival and other related information to support a comprehensive evaluation of patients with thymidine kinase 2 deficiency (tk2d) who have not been treated with pyrimidine nucleos(t)ides including deoxycytidine monophosphate/deoxythymidine monophosphase (dcmp/dtmp), and deoxycytidine/deoxythymidine (dc/dt), and/or mt1621(dc/dt), and those that have received one or more of these treatments. the secondary goals of this study will focus on describing the participant's clinical course and treatment experience.

Eligibility criteria:
inclusion criteria: 1. signed informed consent by the subject or parent(s)/lar and/or assent by the subject (when applicable), unless the associated irb or ec provides an appropriate consent waiver that allows review of medical records for this study. 2. confirmed genetic mutations in the tk2 gene. 3. availability of medical records or information pertaining to vital status at a minimum. exclusion criteria: not applicable as this is a non-interventional study.

Keywords: tk2d mitochondrial disorder mitochondrial disease mitochondria primary mitochondrial myopathy mitochondrial depletion syndrome muscle weakness muscle atrophy loss of mobility
different injection site maps & intravesical botulinum toxin

Conditions: Bladder Disease

Summary: botulinum toxin injection into the bladder is used in current practice in urological diseases such as overactive bladder or interstitial cystitis. as far as is known, botulinum toxin injection sites have not been clearly defined. in this study, investigators are planning to compare botulinum toxin effectiveness with different injection site maps.


Eligibility criteria:
inclusion criteria: * older than 18 years * interstitial cystitis patients * overactive bladder exclusion criteria: * younger than 18 years

Keywords: botulinum toxin overactive bladder interstitial cystitis
comparison of open and laparoscopic appendectomy in pediatric population

Conditions: Appendicitis Acute

Summary: introduction: in the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy. objectives: to compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay.

a total of 100 children presenting with acute appendicitis were included in this study, in group a, patients were undergone laparoscopic appendectomy. in group b, patients were undergone open appendectomy. during surgery, operative time was noted. after surgery, patients were shifted to surgical wards and were followed-up there till discharge. patients were followed regularly by the researcher for mean post-operative pain at 24 hours. at discharge, hospital stay was noted. then patients followed up in outpatient department for 10 days for any evidence of wound infection.

Eligibility criteria:
inclusion criteria: 1. children of age 7-12 years of either gender diagnosed as acute appendicitis 2. pediatric appendicitis score \>4 exclusion criteria: 1. children with comorbidities, 2. perforated appendix 3. appendicular mass (on clinical examination). -

Keywords: appendicitis children laparoscopic appendectomy open appendectomy
study of ngm438 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors

Conditions: Pancreatic Cancer; Breast Cancer; Gastric Cancer; Non Small Cell Lung Cancer; Cervical Cancer; Endocervical Cancer; Squamous Cell Carcinoma of Head and Neck; Bladder Urothelial Cancer; Colorectal Cancer; Esophageal Cancer; Ovarian Cancer; Renal Cell Carcinoma; Prostate Cancer; Melanoma; Mesothelioma; Cholangiocarcinoma

Summary: study of ngm438 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented locally advanced or metastatic solid tumor malignancy. * progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type for which the patient was eligible and willing to receive. * adequate bone marrow, kidney and liver function * performance status of 0 or 1. * resolved acute effects of any prior therapy to baseline severity or ctcae grade 1 except for aes not constituting a safety risk by investigator judgement. exclusion criteria: • prior treatment targeting lair1